Efficacy of 5% Chitosan Nanoparticle Paste in the Treatment of Recurrent Aphthous Stomatitis

NCT07702474 | Completed Phase 2

• 1 other identifier: IR.KMU.REC.1388.111
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the therapeutic clinical efficacy of a synthesized 5 wt.% chitosan nanoparticle paste compared to a standard topical corticosteroid (triamcinolone acetonide 0.1% oral paste) in patients suffering from minor recurrent aphthous stomatitis. The study specifically monitors changes in clinical ulcer diameter and pain reduction.

Conditions

Recurrent Aphthous Stomatitis; Oral Ulcers

Keywords

Chitosan; Nanoparticles; Triamcinolone Acetonide; Aphthous Ulcers; Wound Healing

Outcome Measures

Primary Outcomes (1)

• Change in clinical ulcer diameter

  Measured in millimeters using a Hu-Friedy periodontal probe to evaluate clinical wound contraction and reduction in lesion size.

  Days 0, 1, 6, and 10

Secondary Outcomes (1)

• Change in pain severity score

  Days 0, 1, 6, and 10

Study Arms (2)

Active Comparator: Triamcinolone Group

ACTIVE COMPARATOR

Patients received triamcinolone acetonide 0.1% oral paste (Adcortyl) applied topically 4 times a day until complete healing.

Drug: Triamcinolone Acetonide 0.1% Oral Paste

Experimental: Chitosan Nanoparticle Group

EXPERIMENTAL

Patients received mucoadhesive 5 wt.% chitosan nanoparticle paste applied topically 4 times a day until complete healing.

Drug: 5 wt.% Chitosan Nanoparticle Paste

Interventions

Triamcinolone Acetonide 0.1% Oral Paste DRUG

Standard reference topical corticosteroid ointment utilized as the active standard of care control.

Also known as: Adcortyl

Active Comparator: Triamcinolone Group

5 wt.% Chitosan Nanoparticle Paste DRUG

Synthesized via ionic gelation method using low molecular weight chitosan and sodium tripolyphosphate, formulated into a 5 wt.% mucoadhesive paste.

Also known as: Chitosan Paste, CN

Experimental: Chitosan Nanoparticle Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients complaining of oral recurrent ulcers with signs of minor recurrent aphthous stomatitis.
• History of oral recurrent ulcers with a recurrence rate of 2 to 3 times per year.
• Ulcer diameter less than 1 cm at baseline.
• Maximum of 4 days passed since the emergence of the current ulcer.
• No use of any prior medications or treatment for the current ulcer.
• Signed written informed consent.

You may not qualify if:

• Background of systemic diseases, including diabetes mellitus.
• Connective tissue diseases such as Lupus.
• Syndromes or diseases related to aphthous ulcers, such as cyclic neutropenia and Behcet's disease.

Sponsors & Collaborators

• Kerman University of Medical Sciences: lead

MeSH Terms

Conditions

Stomatitis, Aphthous; Oral Ulcer

Interventions

Triamcinolone Acetonide; Ointments; Gramicidin, Neomycin Sulfate, Nystatin, Triamcinolone Acetonide Drug Combination

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To ensure rigorous single-blinding, medications were dispensed in masked, identical containers by an independent coordinator. The clinical investigator performing all follow-up measurements and scoring was completely blinded to the treatment assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Oral Medicine

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 14, 2026
• Study Start: April 21, 2009
• Primary Completion: November 3, 2009
• Study Completion: December 1, 2009
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share